This test can only be ordered alone if there is a previous positive reported HPV High Risk (50070) and if the patient is a female ≥ 30 years of age. Any other exception will have to be approved by a pathologist.

This test detects the high-risk HPV genotypes, 16 and 18/45 only and does not detect other high-risk genotypes (31, 33, 39, 35, 51, 52, 56, 58, 59, 66 and 68 also associated with cervical cancer and its precursor lesions. Cross-reactivity with high levels of high-risk HPV genotype 31 has been observed and may return an HPV 16-positive result.

High concentrations of HPV 45 can reduce the ability to detect HPV 16 at low levels.